(b)(4).D10: cat# 01.29.242a, lot# 2304662, mectacer biolox taper.Cat# 01.29.232h, lot# 2106000, mectacer ceramic head.G2: foreign ¿ australia.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 02574.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it is still implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing.Medical records/radiographs were reviewed by a health care professional and identified findings of the reported issues.Impressions: anatomic alignment of the right hip arthroplasty.A definitive root cause cannot be determined, however there was a competitor head used with a zimmer biomet liner.It¿s unknown if this caused or contributed to the reported event.The event is not confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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